K Number

Device Name

ARCPM 1050 RESIN-HIPS

Manufacturer

BIOMET ORTHOPEDICS, INC.

Date Cleared

2002-11-06

(30 days)

Product Code

LPH JDI LZO

Regulation Number

888.3358

Intended Use

The products found in the original 510(k) K950761, and K954417 will use the following Indications for Use: 1) NonInfiammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functional deformity, 4) Revision procedures where other treatments or devices have failed and 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head Involvement, unmanageable using other techniques. For Cemented and Non-cemented use The products found in the original 510(k) K920639, K920640 and K926107 will use the following Indications for Use: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functional deformity, 4) Revision procedures where other treatments or devices have failed and 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. For Cemented use only The products found in the original 510(k) K921274 will use the following Indications for Use: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functional deformity, 4) Revision procedures where other treatments or devices have falled and 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. For Non-Cemented use only The products found in the original 510(k) K970501 will use the following Indications for Use: Intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses. The device is a single use implant

Device Description

Biomet's polyethylene components are manufactured from UHMWPE (GUR 1050) resin conforming to ASTM F-648, ISO 5834-1, and ISO 5834-2. This resin is isostatically compression molded under constant temperature and pressure and formed into acetabular components, which are designed to replace the articulating portion of the hip joint.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K950761, K920640, K926107, K920639, K921274, K954417, K970501

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a hip joint implant made of UHMWPE and its intended uses and performance testing, with no mention of AI or ML.

Therapeutic

Yes
The device is described as an implant designed to replace the articulating portion of the hip joint for the reconstruction of the hip joint due to disease, deformity, or trauma, indicating a direct therapeutic action.

Diagnostic

No
The device is described as "Biomet's polyethylene components... formed into acetabular components, which are designed to replace the articulating portion of the hip joint." This indicates it is a therapeutic implant, not a diagnostic tool. The "Indications for Use" also describe conditions the device is intended to treat, further supporting its therapeutic nature.

SaMD (Software as a Medical Device)

The device description explicitly states it is a physical component ("polyethylene components are manufactured from UHMWPE") designed to replace a portion of the hip joint, indicating it is a hardware device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Description: The device described is a polyethylene component designed to replace the articulating portion of the hip joint. This is an implantable medical device used within the body.
Indications for Use: The indications for use all relate to treating conditions of the hip joint through surgical implantation. They do not involve the analysis of in vitro specimens.

Therefore, this device falls under the category of an implantable surgical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The products found in the original 510(k) K950761, and K954417 will use the following Indications for Use:

NonInfiammatory degenerative joint disease including osteoarthritis and avascular necrosis,
Rheumatoid arthritis,
Correction of functional deformity,
Revision procedures where other treatments or devices have failed and
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head Involvement, unmanageable using other techniques.
For Cemented and Non-cemented use

The products found in the original 510(k) K920639, K920640 and K926107 will use the following Indications for Use:

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
Rheumatoid arthritis,
Correction of functional deformity,
Revision procedures where other treatments or devices have failed and
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
For Cemented use only

The products found in the original 510(k) K921274 will use the following Indications for Use:

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
Rheumatoid arthritis,
Correction of functional deformity,
Revision procedures where other treatments or devices have falled and
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
For Non-Cemented use only

The products found in the original 510(k) K970501 will use the following Indications for Use:
Intended for use in reconstruction of the hip joint due to disease, deformity of trauma The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses.
The device is a single use implant

Product codes (comma separated list FDA assigned to the subject device)

LPH, JDI, LZO

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hip joint

Indicated Patient Age Range

skeletally mature individuals

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing: The following verification activities were performed on GUR 1050 resin: Process Validation (tensile, impact, and physical properties), Hip Simulator, Aging behavior and shelf life. All of which met or exceeded current standards or guidelines; therefore, substantially equivalent to the predicate device.
Clinical Testing: None provided as a basis for substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K950761, K920640, K926107, K920639, K921274, K954417, K970501

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.

Summary

023357

BIOMET

6 2002 NOV

SUMMARY OF SAFETY AND EFFECTIVENESS

| Sponsor: | Biomet, Inc.
56 East Bell Drive
P.O. Box 587
Warsaw, IN 46581-0587 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tracy J. Bickel
(574) 267-6639 |
| Proprietary Name: | ArCom® Polyethylene Liners and Components |
| Common Name: | UHMWPE |
| Classification Name: | -hip joint metal/polymer semi-constrained porous coated uncemented prosthesis
(888.3358)
-hip joint metal/polymer semi-constrained cemented prosthesis (888.3350)

prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-
porous, uncemented (888.3353) |
| Substantially Equivalent Devices: | Please see the attached page(s) for the specific equivalent devices. |
| Device Description: | Biomet's polyethylene components are manufactured from UHMWPE (GUR

resin conforming to ASTM F-648, ISO 5834-1, and ISO 5834-2. This resin
is isostatically compression molded under constant temperature and pressure and
formed into acetabular components, which are designed to replace the articulating
portion of the hip joint. |
| Indications for Use: | Please see the attached page(s) for the specific indications for use statements. |
| Summary of Technologies: | The UHMWPE resin has been changed from 1900H to GUR 1050. The
devices' technological characteristics (materials, design, sizing, and
indications) are similar or identical to the predicate device. |
| Non-Clinical Testing: | The following verification activities were performed on GUR 1050 resin: Process
Validation (tensile, impact, and physical properties), Hip Simulator, Aging behavior
and shelf life. All of which met or exceeded current standards or guidelines;
therefore, substantially equivalent to the predicate device. |
| Clinical Testing: | None provided as a basis for substantial equivalence. |

All trademarks are property of Biomet, Inc.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

를

OFFICE 574.267.6639

E-MAIL blomet@biomet.com

比023357

p. 2 of 3

SS&E Page 2
ArCom® Polyethylene Liners and Components

| 510(k)

Number	Device Description	Indications for Use
K920640
K926107	Ringloc UHMWPE Hi-Wall
22, 26, 28, and 32 mm
Ringloc UHMWPE 10°
22, 28, and 32mm	1. Noninflammatory degenerative joint disease
including osteoarthritis and avascular necrosis,

Rheumatoid arthritis,
Correction of functional deformity,
Revision procedures where other treatments or
devices have failed and
Treatment of nonunion, femoral neck and
trochanteric fractures of the proximal femur with
head involvement, unmanageable using other
techniques. |
| K920639 | RX 90 std. Hi-Wall
28mm
RX 90 +5 Deep
28mm | For Cemented use only |
| K921274 | Impact Hi-Wall
28 and 32mm | 1) Noninflammatory degenerative joint disease
including osteoarthritis and avascular necrosis,

Rheumatoid arthritis,
Correction of functional deformity,
Revision procedures where other treatments or
devices have failed and
Treatment of nonunion, femoral neck and
trochanteric fractures of the proximal femur with
head involvement, unmanageable using other
techniques.
For Non-Cemented use only |
| K926107 | Mod. Hi-Wall LNR
28 and 32mm
Mod. 10° LNR
28 and 32mm
RX 90 std. Hi-Wall
28mm
RX 90 +5 Deep
28mm | 1. Noninflammatory degenerative joint disease
including osteoarthritis and avascular necrosis,

Rheumatoid arthritis,
Correction of functional deformity,
Revision procedures where other treatments or
devices have failed and
Treatment of nonunion, femoral neck and
trochanteric fractures of the proximal femur with
head involvement, unmanageable using other
techniques.
For Cemented use only |
| 510(k)
Number | Device Description | Indications for Use |
| K950761 | Ringloc UHMWPE Hi-Wall
22, 26, 28, and 32 mm
Ringloc UHMWPE 10°
22, 28, and 32mm
Ringloc LP Hi-Wall
Arcom
22, 28, and 32mm
Ringloc Arcom LP 10°
22, 28, and 32mm | 1. Noninflammatory degenerative joint disease
including osteoarthritis and avascular necrosis,
Rheumatoid arthritis,
Correction of functional deformity,
Revision procedures where other treatments ordevices have failed and
Treatment of nonunion, femoral neck and
trochanteric fractures of the proximal femur with
head involvement, unmanageable using other
techniques. |
| K954417 | Arcom +5mm | For Cemented and Non-cemented use |
| K950761
K954417 | Arcom Std. Face
28and 32mm
Arcom Hi-Wall
22, 26, 28, and 32mm
Arcom 10°
22, 26, 28, and 32 mm | |
| | Arcom 10° Hi-Wall
28 and 32mm | |
| K970501 | Arcom Std. Face
28 and 32mm
Arcom Hi-Wall
22, 26, 28, and 32mm
Arcom 10°
22, 26, 28, and 32 mm
Arcom 10° Hi-Wall
28 and 32mm
Arcom +5
28mm | Intended for use in reconstruction of the hip joint due
to disease, deformity of trauma. The device is intended
for cemented application for general use and non-
cemented application in skeletally mature individuals
undergoing primary surgery for rehabilitating hip joints
damaged as a result of non-inflammatory degenerative
joint disease or any of its composite diagnoses.
Single use implant |

023357

SS&E Page 3
ArCom® Polyethylene Liners and Components

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally oriented. The words are stacked on a single line and are evenly spaced.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ·

Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw. Indiana 46581-0587

Re: K023357

Trade/Device Name: ArCom® Polyethylene Liners and Components Regulation Number: See Enclosed List Regulation Name: See Enclosed List Regulatory Class: Class II Product Code: See Enclosed List Dated: October 4, 2002 Received: October 7, 2002

Dear Ms. Bickel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

2002

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Page 2 - Ms. Tracy J. Bickel

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D.
Director Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

(1) Indications for Use Forms (4 pages)

(2) Classification Table (2 pages)

EnclosurE :

politici fi ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Product | Product
Code | Classification
Nomenclature | Class.
Code | 510(k) |
|-------------------------------------------------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-------------------------------|
| Ringloc UHMWPE Hi-Wall
22, 26, 28, and 32 mm | LPH and
JDI | LPH- hip joint metal/polymer semi-constrained porous
coated uncemented prosthesis
JDI- hip joint metal/polymer semi-constrained cemented
prosthesis | 888.3358
888.3350 | K950761 |
| Ringloc UHMWPE Hi-Wall
22, 26, 28, and 32 mm | JDI | JDI- hip joint metal/polymer semi-constrained cemented
prosthesis | 888.3350 | K920640
K926107 |
| Ringloc UHMWPE 10°
22, 28, and 32mm | LPH and
JDI | LPH- hip joint metal/polymer semi-constrained porous
coated uncemented prosthesis
JDI- hip joint metal/polymer semi-constrained cemented
prosthesis | 888.3358
888.3350 | K950761 |
| Ringloc UHMWPE 10°
22, 28, and 32mm | JDI | JDI- hip joint metal/polymer semi-constrained cemented
prosthesis | 888.3350 | K920640
K926107 |
| Ringloc LP Hi-Wall Arcom
22, 28, and 32mm | LPH and
JDI | LPH- hip joint metal/polymer semi-constrained porous
coated uncemented prosthesis
JDI-hip joint metal/polymer semi-constrained cemented
prosthesis | 888.3358
888.3350 | K950761 |
| Ringloc Arcom LP 10°
22, 28, and 32mm | LPH and
JDI | LPH- hip joint metal/polymer semi-constrained porous
coated uncemented prosthesis
JDI- hip joint metal/polymer semi-constrained cemented
prosthesis | 888.3358
888.3350 | K950761 |
| Arcom Std. Face
28and 32mm | LPH and
JDI | LPH- hip joint metal/polymer semi-constrained porous
coated uncemented prosthesis
JDI- hip joint metal/polymer semi-constrained cemented
prosthesis | 888.3358
888.3350 | K950761
K970501
K954417 |
| Arcom Hi-Wall
22, 26, 28, and 32mm | LPH and
JDI | LPH- hip joint metal/polymer semi-constrained porous
coated uncemented prosthesis
JDI- hip joint metal/polymer semi-constrained cemented
prosthesis | 888.3358
888.3350 | K950761
K970501
K954417 |
| Arcom 10°
22, 26, 28, and 32 mm | LPH and
JDI | LPH- hip joint metal/polymer semi-constrained porous
coated uncemented prosthesis
JDI- hip joint metal/polymer semi-constrained cemented
prosthesis | 888.3358
888.3350 | K950761
K970501
K954417 |
| Arcom 10° Hi-Wall
28 and 32mm | LPH and
JDI | LPH- hip joint metal/polymer semi-constrained porous
coated uncemented prosthesis
JDI- hip joint metal/polymer semi-constrained cemented
prosthesis | 888.3358
888.3350 | K950761
K970501
K954417 |
| Product | Product
Code | Classification
Nomenclature | Class.
Code | 510(k) |
| Arcom +5
28mm | LPH and
JDI | LPH- hip joint metal/polymer semi-constrained porous
coated uncemented prosthesis | 888.3358 | K970501 |
| | | JDI- hip joint metal/polymer semi-constrained cemented
prosthesis | 888.3350 | K954417 |
| Mod. Hi-Wall LNR
28 and 32mm | JDI | JDI- hip joint metal/polymer semi-constrained cemented
prosthesis | 888.3350 | K926107 |
| Mod. 10° LNR
28 and 32mm | JDI | JDI- hip joint metal/polymer semi-constrained cemented
prosthesis | 888.3350 | K926107 |
| RX 90 std. Hi-Wall
28mm | JDI | JDI- hip joint metal/polymer semi-constrained cemented
prosthesis | 888.3350 | K920639
K926107 |
| RX 90 +5 Deep
28mm | JDI | JDI- hip joint metal/polymer semi-constrained cemented
prosthesis | 888.3350 | K920639
K926107 |
| Impact Hi-Wall
28 and 32mm | LZO
LPH | LZO- prosthesis, hip, semi-constrained,
metal/ceramic/polymer, cemented or non-porous,
uncemented | 888.3353
888.3358 | K921274 |
| | | LPH- hip joint metal/polymer semi-constrained porous
coated uncemented prosthesis | | |

Enclosure :

・

2 L U +

Page 1 of 4.

KU23357 510 (k) Number (if known) :

Device Name: Arcom® Polyethylene Liners and Components

Indications for Use: The products found in the original 510(k) K950761, and K954417 will use the following Indications for Use:

1. NonInfiammatory degenerative joint disease including osteoarthritis and avascular necrosis,
1. Rheumatoid arthritis,
1. Correction of functional deformity,
1. Revision procedures where other treatments or devices have failed and
1. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head Involvement, unmanageable using other techniques.

For Cemented and Non-cemented use

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109) OR

Over-The-Counter-Use_ (Optional Format 1-2-96)

Page 2 of 4.

510 (k) Number (if known) :

Device Name: Arcom® Polyethylene Liners and Components

Indications for Use: The products found in the original 510(k) K920639, K920640 and K926107 will use the following Indications for Use:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
Rheumatoid arthritis, 2)
1. Correction of functional deformity,
1. Revision procedures where other treatments or devices have failed and
1. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

For Cemented use only

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use_ (Optional Format 1-2-96)

Muriam C. Provost
(Division Sign Off)

(Division Sien-Off) Division of General, Restorative and Neurological Devices

510(k) Number K023357

Page 3 of 4

20233 510 (k) Number (if known) :

Device Name: Arcom® Polyethylene Liners and Components

Indications for Use: The products found in the original 510(k) K921274 will use the following Indications for Use:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
Rheumatoid arthritis,
Correction of functional deformity,
Revision procedures where other treatments or devices have falled and
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

For Non-Cemented use only

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K023357

Page of

02335 510 (k) Number (if known) :

Device Name: Arcom® Polyethylene Liners and Components

Indications for Use: The products found in the original 510(k) K970501 will use the following Indications for Use:

Intended for use in reconstruction of the hip joint due to disease, deformity of trauma The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses.

The device is a single use implant

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K023357